The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement

NCT ID: NCT06322797

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-19
• Study Completion Date: 2024-12-31

Brief Summary

A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.

Detailed Description

Some studies related to rTMS for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. It is known that function is restored through various neurophysiological changes.

However, there are not many studies on rTMS in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment.

Recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fMRI (Functional Magnetic Resonance Imaging) are being used in various fields.

Based on the idea in this regard, recent studies have been conducted that the effect of rTMS treatment is better than the existing method when fMRI is used to identify the brain regions involved in the movement of the upper and lower extremities.

The purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fMRI and rTMS.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

rTMS over the M1 cortex of the injured hemisphere localized by motor action potential

Experimental A group : rTMS was administered by trained physicians over the M1 cortex of the injured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. First, the resting motor threshold was measured for each patient. At the lowest stimulus output, a stimulus was applied to the M1 cortex of the uninjured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. The resting motor threshold was defined as the intensity required to generate a motor-induced potential of > 50 uV in the contralateral abductor pollicis brevis muscle at least 5 out of 10 times with 30 s of inter-stimulus time interval.

Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min.

rTMS over the specific site of the injured hemisphere localized by fMRI

Experimental B group : rTMS was administered by trained physicians over the specific site which is after checking the brain site activated during finger tapping during fMRI imaging, target coordinates are set based on the 10-20 EEG system coordinate system in the taken MRI image.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. After identifying the brain site that is activated during finger tapping during fMI, Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min. the resting motor threshold was measured for each patient at target brain site.

Sham group

Sham group: shame rTMS( sound mode) is applied over the M1 cortex of the injured hemisphere which is the site that caused the largest visible twitch in the participant's thumb when stimulation is applied

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

In Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups.

Interventions

rTMS

Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. First, the resting motor threshold was measured for each patient. At the lowest stimulus output, a stimulus was applied to the M1 cortex of the uninjured hemisphere aiming at the site that caused the largest visible twitch in the participant's thumb. The resting motor threshold was defined as the intensity required to generate a motor-induced potential of > 50 uV in the contralateral abductor pollicis brevis muscle at least 5 out of 10 times with 30 s of inter-stimulus time interval.

Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min.

Intervention Type: DEVICE

rTMS

Stimulation was performed using a biphasic stimulator (ALTMS® Remed, Republic of Korea) and a 70-mm figure-eight coil. The routine stimulation procedure is described as follows. After identifying the brain site that is activated during finger tapping during fMI, Stimulation was given at 100% of the resting motor threshold stimulator output: 20 Hz, 5-s train duration, 55-s inter-train interval, and a total number of stimulations of 2000 pulses per session for 20 min. the resting motor threshold was measured for each patient at target brain site.

Intervention Type: DEVICE

Sham

In Sound Mode, no actual stimulation is applied, and 20 minutes of treatment is performed like other experimental groups.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults over 20 years of age
• Patients 3 months or more after stroke onset
• Patients with NIHSS score of 1 or more to 20 or less
• After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions

Exclusion Criteria

• Patients with systemic infectious disease at the time of participation in the clinical trial
• In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
• Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
• Other cases where the researcher determines that participation in this clinical trial is not appropriate
• Those who are contraindicated in repetitive transcranial magnetic stimulation A. When metal materials (deep brain stimulation electrode, brain aneurysm clip, cardiac pacemaker, etc.) are in the body B. Uncontrolled epilepsy (epilepsy), patients with psychiatric disorders
• Pregnant, lactating women and patients with potential for pregnancy
• Patients with contraindications for imaging tests
• Those who have undergone cerebral surgery due to past or current related medical history

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MinYoung Kim, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

MinYoung Kim, MD, PhD

Professor of CHA university, M.D., Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kim MinYoung, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kim MinYoung, M.D., Ph.D.

Role: CONTACT

kmin@cha.ac.kr

82-31-780-6281

Kim JongMoon, M.D.

Role: CONTACT

khan1013@chamc.co.kr

82-31-780-6281

Facility Contacts

MinYoung Kim, MD,PhD

Role: primary

parkmijin@chamc.co.kr

82-31-780-2954 ext. 2954

Other Identifiers

rTMSinStroke

Identifier Type: -

Identifier Source: org_study_id